MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-21 for PIK LINE manufactured by .
[20358729]
Occupational therapist took trash bag out of dirty trash and wrapped pic line with this contaminated trash bag to "keep it dry" while he went to pt/ot and warm springs rehab hosp in san antonio. About 5 days later, pt spiked fever and blood cultures ultimately revealed contamination of pik line that had been placed for 3 weeks without any problem up to this point. Pik line, contaminated by staff occupational therapist by covering with plastic bag out of contaminated trash can. She lifted dirty bag up and took extra bags from under full trash bag and wrapped around pik line - [product developer should never teach facilities to use trash bags not intended for sterile coverage> this is taught< and you get an unsophisticated person that uses dirty material to cover what should be a sterile area. ]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027895 |
| MDR Report Key | 2856668 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-11-21 |
| Date of Event | 2011-10-05 |
| Date Added to Maude | 2012-12-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIK LINE |
| Generic Name | PIK LINE |
| Product Code | OKC |
| Date Received | 2012-11-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-11-21 |